Please note, this OEL/ADE monograph also applies to Salmeterol base (CAS RN 89365-50-4). Salmeterol xinafoate, an adrenergic beta2 receptor agonist, is used to treat asthma and chronic obstructive pulmonary disease (COPD) and to prevent exercise-induced bronchospasm (narrowing of airways). Beta2-adrenoreceptors are located on smooth muscles of the bronchi (airways in the lungs). Beta2-adrenoreceptor agonists stimulate adenylyl cyclase resulting in an increase cyclic AMP. An increase in cyclic AMP causes relaxation of the smooth muscles of the bronchi (airways in the lungs) and, also inhibits the release mediators of hypersensitivity.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.